Featured Company News - Portola Pharmaceuticals' AndexXa(R) Biologics License Application Resubmission Accepted for Review by US FDA
Research Desk Line-up: Alnylam Pharma Post Earnings Coverage
LONDON, UK / ACCESSWIRE / August 17, 2017 /Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Portola Pharmaceuticals, Inc. (NASDAQ: PTLA) ("Portola"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=PTLA. The Company announced on August 15, 2017, that the US Food and Drug Administration (FDA) have found its resubmitted Biologics License Application (BLA) for AndexXa® (andexanet alfa) to be acceptable for review, with an action due date of February 02, 2018. For immediate access to our complimentary reports, including today's coverage, register for free now at:
Discover more of our free reports coverage from other companies within the Biotechnology industry. Pro-TD has currently selected Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) for due-diligence and potential coverage as the Company reported on August 09, 2017, its consolidated financial results for Q2 2017, and also highlighted recent progress in advancing its pipeline. Tune in to our site to register for a free membership, and be among the early birds that get our report on Alnylam Pharma when we publish it.
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The License Application Resubmission
Portola resubmitted its BLA to the Center for Biologics Evaluation and Research (CBER) of the US FDA for AndexXa® on August 03, 2017. The resubmission primarily comprises supplemental information related to analytics and manufacturing. This is in sync with what FDA requested in a complete response letter issued to Portola in August 2016.
AndexXa® Designed to Treat Uncontrolled Bleeding
Portola has developed AndexXa® as a universal reversal agent for patients who have been anticoagulated with an oral or injectable Factor Xa inhibitor and experienced a serious uncontrolled or life-threatening bleeding event, or those who require urgent or emergency surgery. The above mentioned BLA basically seeks initial approval of AndexXa® for reversal of the anticoagulant effects of apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.
How AndexXa® Works
AndexXa® (i.e. andexanet alfa) is an investigational drug. It is basically a modified human Factor Xa molecule which acts as a decoy to target and sequester, with high specificity, both oral and injectable Factor Xa inhibitors in the blood. Once the Factor Xa inhibitors are bound, they are unable to bind to and inhibit native Factor Xa. This allows for the restoration of normal hemostatic processes. In fact, AndexXa® is the first compound that is being studied as an antidote for Factor Xa inhibitors that directly and specifically reverse the anti-Factor Xa activity, the anticoagulant mechanism of these agents.
Can Benefit Around 150,000 US Patients
AndexXa® is expected to benefit a vast number of patients in the United States. In 2016, around 90,000 patients in the US treated with oral Factor Xa inhibitors were admitted to the hospital due to subsequent bleeding. It is projected that approximately 150,000 US patients could benefit from an antidote annually, including the patients who are taking the injectable Factor Xa inhibitor enoxaparin. As of now, there are no approved Factor Xa inhibitor antidotes.
Portola Reports Q2 2017 Financial Results
On August 10, 2017, Portola reported financial results and shared a corporate update for the quarter ended June 30, 2017. The Company achieved total revenue of $3.8 million for Q2 2017 compared to $4.2 million for Q2 2016. The Company reported a net loss of $69.7 million in Q2 2017 compared to a net loss of $57.3 million for the same period in 2016. Thus, the net loss per share increased from $1.02 to $1.22.
An important development in the second quarter was the FDA approval for their first product, Bevyxxa®, in June 2017. Bevyxxa® is an oral, once-daily Factor Xa inhibitor.
Last Close Stock Review
Portola Pharma's share price finished yesterday's trading session at $54.70, marginally down 0.56%. A total volume of 650.67 thousand shares have exchanged hands. The Company's stock price soared 38.80% in the last three months, 77.83% in the past six months, and 105.56% in the previous twelve months. Additionally, the stock skyrocketed 143.76% since the start of the year. The stock currently has a market cap of $3.14 billion.
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